Nighttime Sleep Aid

Product NDC: 69732-005
11-digit product format: 697320005
Labeler code: 69732
Product ID: 69732-005_55f8f71f-4c2c-6161-e063-6394a90a6a8e
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, diphenhydramine
Dosage form: TABLET
Route: ORAL
Labeler: Hi-Tech Nutraceuticals, LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-04-30
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 25; 500 mg/1; mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69732-005-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69732-005-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69732-005-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69732-005-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69732-005-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69732-005-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69732-005-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69732-005-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69732-005-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69732-005-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69732-005-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69732-005-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69732-005-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69732-005-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69732-005-01	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Nighttime Sleep Aid
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1
ACETAMINOPHEN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1092189	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a39e2bd6-3d0a-642b-e053-2995a90a42a0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69732-005-01	2024-01-30	C162847	48780-1	1030e365-1698-111a-e063-dadaa90a10e2	Sleep Aid
69732-005-01	2024-01-30	C162847	48780-1	1030e365-1698-111a-e063-dadaa90a10e2	Sleep Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69732-005-01	Nighttime Sleep Aid	30 in 1 BOTTLE, PLASTIC	TABLET	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69732-005	NIGHTTIME SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE) TABLET [HI-TECH NUTRACEUTICALS, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20230101_a39e2bd6-3d0a-642b-e053-2995a90a42a0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 20 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Pain and Fever	ACETAMINOPHEN	Best Choice (Valu Merchandisers Company)	a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c07	2026-03-03	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	HyVee Inc	6820a515-4004-407b-969b-c4069dc0c3b5	2026-02-26	Warnings	Exact identifier application number: M013
Vicks PainQuil LIQUICAPS PAIN RELIEVER	ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	4b1b0e2a-0f58-c3b1-e063-6294a90aa1fb	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen, Diphenhydramine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	LEADER/ Cardinal Health 110, Inc.	7be4d67e-1af9-f059-e053-2991aa0a382e	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	1f4ac0e6-e986-4c22-8248-0691d64e1a30	2026-02-26	Warnings	Exact identifier application number: M013
Childrens Chewable Acetaminophen	ACETAMINOPHEN	Discount Drug Mart	f413a617-1166-4940-b6ec-fae32238a780	2026-02-26	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	CVS Pharmacy	bd11081f-c5d1-4c98-8f5a-4c45269df79b	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	19735691-33f3-4e19-85ad-e5f270251ec5	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Kroger	44520aa1-b63f-4239-e063-6394a90a5e14	2026-02-25	Warnings	Exact identifier application number: M013
Leader Extra Strength Effervescent Antacid and Pain Reliever	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Cardinal Health	c5d7bf5f-3e59-52f2-e053-2a95a90a4a00	2026-02-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	12fd643d-7c60-453f-a81f-407ed20e8725	2026-02-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d96a1531-772b-4a5c-89e4-66fff1fa3d78	2026-02-25	Warnings	Exact identifier application number: M013
Gentle Care Kit	ZINC OXIDE	Kenvue Brands LLC	4b8f7a5a-2fc4-ea00-e063-6294a90ab95b	2026-02-24	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	444fa225-c204-45d1-b3b3-aa5650ee5d07	2026-02-23	Warnings	Exact identifier application number: M013
Excedrin Extra Strength and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	2c8df1c7-7864-48df-939c-d9ae22e0f52c	2026-02-23	Warnings	Exact identifier application number: M013
Vicks PainQuil and Vicks PainQuil PM LIQUICAPS PAIN RELIEVER	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	The Procter & Gamble Manufacturing Company	4b829c72-349a-e52c-e063-6394a90aca8d	2026-02-23	Warnings	Exact identifier application number: M013
Equate Childrens Pain and Fever	ACETAMINOPHEN	Wal-Mart Stores Inc	40eedfe9-54e1-40a2-b4a2-55ff708b89cd	2026-02-23	Warnings	Exact identifier application number: M013
Excedrin Rapid Relief	ACETAMINOPHEN	Haleon US Holdings LLC	3a36b7ca-396e-cfd8-e063-6294a90a76ab	2026-02-22	Warnings	Exact identifier application number: M013
Vicks PainQuil PM LIQUICAPS PAIN RELIEVER plus NIGHTTIME SLEEP-AID	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	The Procter & Gamble Manufacturing Company	4b1ad683-9b5a-622f-e063-6294a90a475c	2026-02-20	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1092189	acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	a39e2bd6-3d0a-642b-e053-2995a90a42a0	3
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	a39e2bd6-3d0a-642b-e053-2995a90a42a0	3
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	a39e2bd6-3d0a-642b-e053-2995a90a42a0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69732-005-01	69732000501	30 TABLET in 1 BOTTLE, PLASTIC (69732-005-01)	30 tablet	2020-04-30	0000-00-00	No	No	Current